Consumer concerns about regulatory safeguards for medical devices

Concerns about insufficient regulatory safeguards for medical devices reflect the differences between these devices and prescription drugs. Historically, most devices were used outside the body (such as scalpels and band-aids), and there was a perception that 'what you see is what you get', making research seem less important. As implanted medical devices have become more common, long-term research has become more important, but the safeguards and resources for regulatory agencies, in the USA and other countries, has not kept up with the increased importance of those devices.

In most countries, medical devices are routinely approved for marketing on the basis of short-term studies. This is also true in the USA, although manufacturers of high-risk devices are often required to do longer-term postmarket studies as a condition of device approval. Postmarket studies that are required because of concerns that arise after product approval, rather than as a condition of approval, are limited by FDA regulations. For example, 3 years is the maximum time that the FDA can impose for postmarket research requirements on medical devices ordered after approval without the agreement of the manufacturer; that is not sufficient to examine long-term safety [17]. Moreover, recent reports by the Institute of Medicine and the FDA indicate that postmarket studies, imposed as a condition of approval, have been inadequately monitored, and that the studies were often not performed or finished [18,19]. Add to that the corporate rationale that devices are constantly being improved and therefore regulatory flexibility is necessary, and there is a clear conflict between consumer demand that products be proven safe and corporate demands that products be approved quickly and be allowed to change without the need for new approval applications. These issues are raised in countries all over the world, and there is not one country that has insisted on or consistently enforced long-term postmarket surveillance of medical devices, not even of those implanted for very long-term use.

FDA regulations differ in the safety criteria for medical devices compared to new drug approvals, and these differences are similar in other countries as well. Drugs must be safe for the uses recommended in labeling, which is interpreted as meaning that the benefits outweigh the risks. In contrast, a medical device must have a 'reasonable assurance of safety', which is more ambiguous; the law requires that the 'probable benefits to health' should outweigh 'any probable risks' (21CFR860.7). This has been interpreted as a less stringent criterion for safety and effectiveness, where scientific proof that the benefits outweigh the risks is not necessarily required.

In racially and ethnically diverse countries such as the USA, the potential for racial and ethnic differences in responses to implanted medical devices has become an issue of concern among consumer groups. The NRC for Women & Families, the National Medical Association, and the Congressional Black Caucus of the US Congress have all expressed their concern that implant makers rarely include racial and ethnic minorities in their studies. Since individuals of African or Asian ancestry are more likely to have keloid scarring, and since individuals of African ancestry are more susceptible to autoimmune diseases, medical implants may be more risky for those groups. However, it is impossible to know whether this is the case if no studies have been done.

Consumer groups have the opportunity to influence regulatory decisions in countries using independent advisory panels, such as is the case in the USA and Canada. Consumers are represented on the advisory panels and also have the opportunity to speak during the open public comment periods. However, whatever the roles consumers play, there is reason to be concerned that advisory panels tend to be a rubber stamp for approval. In a study released in 2006, NRC for Women & Families compared recommendations from FDA advisory panels for medical devices with advisory panels for prescription drugs. Votes between 1998 and 2005 were compared for five randomly selected device advisory panels and six randomly selected drug advisory panels. During those 8 years, the advisory panels recommended approval for 82% of medical devices that they reviewed, compared to 76% of prescription drugs under review. Some panel members always voted for approval for any product during their entire tenure on the advisory panel. NRC for Women & Families concluded that the less stringent criteria for approval for medical devices created an expectation that most medical devices were 'reasonably safe' and therefore suitable for FDA approval. Although panel members often expressed concern about the lack of safety information, they apparently assuaged those concerns by recommending postmarket studies and other conditions of approval. Unfortunately, as discussed later in this chapter, postmarket studies and surveillance are often not enforced [18].

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